Onset Time of Nerve Block: A Comparison of Two Injection Locations in Patients Having Lower Leg/ Foot Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Ochsner Health System
Sponsor:
Information provided by (Responsible Party):
Kristie Osteen, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01542840
First received: February 27, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a nerve or nerves that provide sensation to the area where surgery will be performed. The local anesthetic (numbing medication) numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can be injected in various patterns by a nerve, such as in one spot by a nerve or completely surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve.

The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve.


Condition
Strain of Muscle and/or Tendon of Lower Leg
Fracture of Lower Leg
Crushing Injury of Lower Leg
Fracture Malunion - Ankle and/or Foot
Disorder of Joint of Ankle and/or Foot
Complete Tear, Ankle and/or Foot Ligament
Pathological Fracture - Ankle and/or Foot
Loose Body in Joint of Ankle and/or Foot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Onset Time of Ultrasound-Guided Popliteal Sciatic Nerve Block: Comparing Circumferential Injection of Local Anesthetic to Injection That Separates the Nerve in Its Two Components

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Estimated Enrollment: 76
Study Start Date: May 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Detailed Description:

After the consent form is signed, subjects will be randomly assigned (like the flip of a coin) to either receive the local anesthestic (numbing medication) around the sciatic nerve or in a pattern that separates the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve.

Before the nerve block is performed, the movement and sensation in the subject's foot will be checked to make sure it is normal. They will be asked to move their foot up and down. Using a blunt safety needle, their foot will be gently touched in different places to see if they can feel sharp sensations.

The amount of relaxation medication before the block will be recorded. The local anesthetic (numbing medication) will be injected in the pattern subjects were randomly assigned. The time it takes from the moment they are asked to say their name and birthday until they cannot move or feel their foot will be recorded.

Five minutes from the time the injection is complete, subjects will be asked to move their foot up and down. Also, their foot will be gently touched in different places with a blunt safety needle to see if they can still feel sharp sensations. Subjects will be asked to do this every five minutes until they cannot feel any sensation in their foot or if thirty minutes pass.

A member of the study team will contact subjects by telephone in about a week to see if they have any pain, numbness, and/or weakness in their leg/foot.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing lower leg and/or foot surgery at Ochsner Clinic Foundation's Main Campus.

Criteria

Inclusion Criteria:

  • undergoing lower leg and/or foot surgery
  • ASA Physical status I-III
  • ability to give informed consent
  • age 18 years old or older

Exclusion Criteria:

  • true allergy to local anesthetics, not sensitivity, as determined by investigator
  • bilateral lower extremity surgery
  • patient refusal
  • infection at the injection site
  • peripheral neuropathy of lower extremity as documented by electromyography studies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542840

Locations
United States, Louisiana
Ochsner Clinic Foundation Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Kristie D Osteen, MD    504-842-3755    kosteen@ochsner.org   
Principal Investigator: Kristie D Osteen, MD         
Sponsors and Collaborators
Ochsner Health System
Investigators
Principal Investigator: Kristie D Osteen, MD Ochsner Health System
  More Information

No publications provided

Responsible Party: Kristie Osteen, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01542840     History of Changes
Other Study ID Numbers: 2011.200.C
Study First Received: February 27, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
surgery
orthopedic surgery
foot surgery
leg surgery
ankle surgery
leg
foot
ankle
anesthesia
local anesthesia
regional anesthesia
Ochsner Clinic
Ochsner Hospital
New Orleans
Louisiana
Kristie Osteen, MD

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Spontaneous
Joint Diseases
Leg Injuries
Fractures, Malunited
Joint Loose Bodies
Wounds and Injuries
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014